Basic Principles of the Validation for Good Laboratory Practice Institutes |
Cho, Kyu-Hyuk
(Division of Inhalation Toxicology, Korea Institute of Toxicology, Korea Research Institute of Chemical Technology)
Kim, Jin-Sung (Department of Non-clinical Studies, Korea Institute of Toxicology, Korea Research Institute of Chemical Technology) Jeon, Man-Soo (Korea GMP Academy Co., Ltd.) Lee, Kyu-Hong (Division of Inhalation Toxicology, Korea Institute of Toxicology, Korea Research Institute of Chemical Technology) Chung, Moon-Koo (Department of Non-clinical Studies, Korea Institute of Toxicology, Korea Research Institute of Chemical Technology) Song, Chang-Woo (Division of Inhalation Toxicology, Korea Institute of Toxicology, Korea Research Institute of Chemical Technology) |
1 | EPA (1989), 40 CFR Part 160, Good Laboratory Practice Standards |
2 | EU (2003), Guide to Good Manufacturing Practice Annex 15, Qualification and Validation |
3 | Haider, S.I. (2002b), Pharmaceutical Master Validation Plan, The Ultimate Guide to FDA, GMP, and GLP Compliance. St. Lucie Press, pp. 1-36 |
4 | Huber, L. (2005), Compliance Requirements for Equipment and Instrumentation in GLP Studies in Gap Analysis, Risk Assessment, & Master Validation Plan, 21st SQA Annul Meeting Preconference Training, Florida, USA |
5 | KFDA (2008), Principle of Validation for Drug and Pharmaceutical Regulation for Nonclinical Laboratory Studies (Notification No. 2008-5) issued by Korea Food and Drug Administration |
6 | KFDA (2008), Interpretation for Good Laboratory Practice. pp.26-50 |
7 | Korea Pharmaceutical Technique Association (2000), Pharmaceutical Manufacture and Validation. pp. 15-53 |
8 | OECD (1997), OECD Principles of Good Laboratories Practice |
9 | WHO (1996), A WHO Guide to Good Manufacturing Practice (GMP) Requirements, Part 2: Validation |
10 | Yu, I.J., Chung, Y.H., Maeng, S.H., Song, K.S., Lee, Y.M., Chung, H.K., Kim, H.J., Park, J.I., Lee, S.K., Lee, Y.H. and Chang, J.S. (1999), History of Korean GLPs and activities and perspectives of the Korean Society of GLP, Quality Assurance, 7, 57-62 DOI |
11 | Weinberg, S. (2007), Good Laboratory Practice Regulation, Fourth Edition, Informa Healthcare Press, pp. 60-229 |
12 | Yoshihito, O. (1985), Good laboratory practice - principles and present status in Japan, Korean J. of Toxicology, 1, 31-41 과학기술학회마을 |
13 | Yu, I.J., Maeng, S.H., Lee, J.Y., Lee, Y.M. and Chung, H.K.(2000), Designation of a GLP facility by the Korean ministry of environment GLP authority: The case of the center for occupational toxicology, Quality Assurance, 8, 11-17 DOI |
14 | Haider, S.I. (2002a), Validation Standard Operating Procedures, A Step-by-Step Guide for Achieving Compliance in the Pharmaceutical, Medical Device, and Biotech Industries, St. Lucie Press, pp. 3-150 |
15 | Leveson, N. and Turner, C.S. (1993), An investigation of the therac-25 accidents, IEEE Computer, 26, 18-41 DOI |
16 | www.labcompliance.com |
17 | LabComplience (2004), Validation Master Plan, for Equipment, Computer Systems, Networked Systems and Spreadsheet Applications, Ver. 2.07, pp. 1-40 |
18 | Huber, L. (1999), Validation and Qualification in Analytical Laboratories, Interpharm Press, pp. 27-106 |
19 | OECD (1999), Revised Consensus Document, The Study Director in GLP Studies, Environment Monograph No. 99(24) |
20 | US FDA (2003), 21 CFR Part 58, Good Laboratory Practice for Nonclinical Laboratory Studies |
21 | Brockmeyer, P. (2006), 29th Biological GMP and validation Education, Process Validation Fundamentals, pp. 21-28, Risk Based Process Validation Review & Risk Assessment Example, pp. 5-9 |
22 | Bedson, P. and Sargent, M. (1996), The development and application of guidance on equipment qualification of analytical instruments, Accred. Qual. Assur, 1, 265-274 DOI ScienceOn |
23 | KFDA (2005), Good Laboratory Practice Regulation for Nonclinical Laboratory Studies (Notification No. 2005-79) issued by Korea Food and Drug Administration |
24 | International Standard ISO/IEC 17025:2005 (2006), General requirements for the competence of testing and calibration laboratories |
25 | KFDA (2007), Good Clinical Practice Regulation for Nonclinical Laboratory Studies (Notification No. 2007-34) issued by Korea Food and Drug Administration |
26 | Gibson, W. and Powell-Evans, K. (1998), Validation Fundamentals, How to, What to, When to Validate, Interpharm/ CRC, pp. 1-205 |
27 | Yu, J.H. (2004), Risk Assessment for Validation, IVS,www.validation.co.kr |
28 | US FDA (1987), Guideline on General Principles of Process Validation |
29 | Matthews, B.R. (2002), The Devonport incident, the Clothier Report, and related matters - 30 years on, PDA J. Pharm. Sci. Technol., 56, 137-149 |
30 | Bridges, D. (2005), Compliance requirements for equipment and instrumentation in GLP studies, Society of quality assurance first global QA conference 21st SQA annual meeting preconference training, Florida. USA. pp. 1-17 |
31 | MIHWAF (2008), The Pharmaceutical Affairs Act, Annex 2: Good Manufacturing Practice and Quality Standards |
![]() |